FOUR GRADE EVENT
Are AIDS drugs worse than the disease? Don't ask the people who make them.
By Celia Farber
After 20 years of hysteria, alarmism, misplaced recrimination and guilt,
AIDS fatigue has beaten the newspaper-reading mind into a kind of blank.
Citizens can't be faulted for not knowing how exactly to respond to last
week's eruption of scandal from an NIH whistle-blower named Jonathan
Fishbein, an AIDS researcher charged with overseeing clinical trials here
and abroad. A reverberating language of bureaucracy and euphemism
surrounds AIDS stories, making it impossible to know what has actually
transpired. When people die from AIDS drugs, for instance, the word
"death" is studiously avoided. I have seen medical articles documenting
the fact that more people now die of toxicities from AIDS drugs than from
the vanishingly opaque syndrome we once called AIDS. Death was referred to
as a "grade four event," thus placing it eerily within the acceptable
parameters of predictable phenomena in AIDS research—not as a failure, a
crisis or even something to lament.
John Solomon broke the first in a series of stories in the Associated
Press on Dec. 14. The lede read:
Weeks before President Bush announced a plan to protect African babies
from AIDS, top US health officials warned that research in Uganda on a key
drug was flawed and may have underreported severe reactions, including
deaths, government documents show.
The story held many shocking revelations, but was quickly spun upside-down
and inside-out by the AIDS spin machine, which can take any horror and
reduce it to banality, keeping the strict focus off of government
malfeasance. What Fishbein disclosed was that NIH AIDS research chief
Edmund Tramont had airbrushed and cooked damning clinical data from a
large experimental trial in Uganda that tested a drug called Nevirapine
against AZT, in pregnant HIV-antibody-positive women, intended to reduce
HIV transmission. Tramont had censored reports of thousands of toxic
reactions to the drug, and "at least 14 deaths," concealing from the White
House the truth about the drug, just before Bush rolled out his $500
million plan to push Nevirapine across Africa.
Additional data not widely reported in the media revealed that there were
16 more deaths in babies on Nevirapine, bringing the total to 30, and 38
babies died on AZT (the other arm of the study). The ominous data
coincided with findings from an aborted study in South Africa in the late
1990s (stopped due to toxicities and deaths); it was disturbing enough
that the drug's manufacturer, Boehringer Ingelheim, withdrew its
application to have the FDA approve the drug for use in pregnant women in
all Western nations, including the U.S.
In 2000, the FDA put out a black-box label on the drug (which is approved
for use in HIV-positive adults as part of a "cocktail therapy"), warning
that it could cause fatal kidney damage and a syndrome that causes the
flesh to blister and peel as though burned.
This is the drug that countless campaigners—spanning the political
spectrum from George Bush to Bono—wish to give all Africans "free access"
to. South African President Thabo Mbeki has been savagely pilloried for
attempting to stop the drug's distribution to black South Africans. South
African lawyer and journalist Anthony Brink's scathing report "The Trouble
With Nevirapine" documented the long-known "problems" with the drug. The
report was widely read by South Africa's leadership, and is the source of
furious debate between black South Africans and the mostly white-run
media, which still ridicules all criticism of U.S.-imported AIDS drugs and
protocols as being a symptom of not caring about AIDS victims.
Nevirapine is a cheap drug, believed to reduce the transmission of HIV
antibodies from mother to child if given before and during birth, despite
there being no reliable data to prove that Nevirapine "drastically
reduce[s]" transmission." (On average, in women who are well nourished,
about eight percent of babies born to HIV-positive mothers with no
intervention wind up HIV-antibody-positive; of these, disease progression
is not tied to HIV status but rather to the overall health of the mother.)
Wild claims about reduction in transmission are based on outdated, flawed
research and ignore critical facts. In Africa, for instance, the test used
to detect for HIV antibodies cross-reacts with the very proteins of
pregnancy, meaning the women may not be true positives to begin with.
Furthermore, every baby carries ghost antibodies from its mother for up to
18 months, which it eventually sheds, so all data about HIV status prior
to that window of time is useless—but consistently cited anyway.
Nevirapine is a non-nucleoside reverse transcriptase inhibitor—a class of
drug designed in the hopes of being less toxic than AZT. This isn't asking
much, since AZT is chemotherapy that simply terminates DNA synthesis.
"Of all the AIDS drugs, Nevirapine is the most acutely toxic," explained
Dr. Dave Rasnick, a fierce critic of the government's AIDS research
agenda, and a former drug developer. "It shows its toxic effects quickly.
It has been documented in the medical literature for years that a single
dose of Nevirapine can kill a person. People don't normally drop dead from
taking a protease inhibitor, but that is what happens with Nevirapine. The
rationale for this stuff is just as bizarre as it could be."
He continued: "Liver toxicity is the leading cause of death of
HIV-positive people in America and Europe in the cocktail era."
Some months ago, I asked Rasnick to send me documentation of this
seemingly unfathomable statement, which he did. The statement is in line
with interviews I did with healthcare workers back in 2000, who reported
that many more people are hospitalized from the effects of the AIDS drugs
than from any of the 30-odd symptoms that originally constituted the
definition of AIDS (i.e., a disintegration of the immune system).
This would seem to be a p.r. problem for the AIDS industry. But as we
learned from the spin that followed the Fishbein revelations, death by
AIDS drugs is not viewed as something that should get in the way of a
well-intentioned research agenda—either in the West or in Africa.
The high dudgeon, when it came, was directed not at the NIH for
experimenting to lethal effect on pregnant Ugandan mothers, cooking and
deleting data, stating openly that African research can't be held to the
same standards as Western research, or any of the other disturbing things
that came out of Tramontgate.
The ire was aimed at the Associated Press and its reporters for spreading
alarm about Nevirapine in Africa, which raised "fears that many women
there will stop taking the drug."
The New York Times led the Orwellian spin, in a December 21 article by
Donald McNeil Jr. The lede went right to the heart of the matter: The
dyspepsia of activists and public health experts.
A series of articles critical of past trials of an important AIDS drug has
created a furor in Africa, causing many public health experts to worry
that some countries will stop using the drug, which prevents mothers from
infecting their babies with the virus that causes AIDS.
It went on: "On Friday, The National Institutes of Health for Allergy and
Infectious Diseases, an arm of the National Institutes of Health, sharply
criticized the articles, saying, 'It is conceivable that thousands of
babies will become infected with HIV and die if single-dose Nevirapine for
mother-to-infant HIV prevention is withheld because of misinformation.'"
Misinformation? The AP stories were specifically about the
transmogrification of information into misinformation that Tramont
engineered for his White House report. He cooked data. He deleted
information about toxic reactions and death. In what kind of inverted
universe is this not a gross violation of the entire premise of science
and medicine?
Nature soon followed suit. From an article dated December 23, this
dizzying opener:
Scientists and patient advocates this week united to defend an HIV
treatment against allegations that a key clinical trial was flawed. A
doctor from Global Strategis for HIV Prevention was quoted: 'This is the
most successful therapy in the entire AIDS epidemic. It should not be
attacked.'
"We are now living in a time of psychotic science, or abnormal science as
I call it," said former New York Native publisher Chuck Ortleb, who was
boycotted by the activist group ACT UP for publishing scathing critiques
of AZT in the 1980s—a drug that was later proven to shorten rather than
lengthen life. "That's why there are no controls in AIDS science, no
dissent, why it's all science by press release. These self-appointed AIDS
czars pretending to speak for the gay community, pretending to be
revolutionaries, pretending to be anti-government when in fact they've
always worked hand in hand with the government."
In recent years, Ortleb has turned to writing satirical novels, plays and
a soon-to-be-released film called The Last Lovers on Earth, which is
centered on a future dystopia in which AIDS research has been so
successful that all gay men are dead.
"With their logic," Ortleb says, "this risk-benefit analysis, it doesn't
matter if people die on the drugs, because they died so that the rest of
the world could be saved."
His most recent send-up is a fictional press release for a new medical
group called "Doctors Without Borders, Brains or Ethics," and focuses on
protecting the AIDS establishment from criticism, "before the infection of
skepticism spreads."
Let us not forget that Nevirapine is a drug that was pulled by its own
manufacturer from use in the West, after an investment of many millions of
dollars. It remains banned for use in pregnant first-world women.
Still, the NIH is using it on American women, in experimental trials you
never heard about—until now. Alongside the revelations about the Ugandan
trial, the AP stories brought to light that Joyce Ann Hafford, a
33-year-old, perfectly healthy, eight-months pregnant HIV-positive woman
from Tennessee died from liver failure in an NIH trial testing Nevirapine.
Her liver counts had been way off for days, and still doctors didn't take
her off the drug.
The doctors told her family, naturally, that she had died of AIDS. The
trouble is, cocktail-drug deaths are easily distinguished from AIDS
deaths. This was not the case with AZT, a drug that simply decimated the
immune system. Cocktail deaths are caused primarily by liver toxicity,
heart attacks and strokes—from the effects of the drugs on the body's fat
metabolism.
Hafford's death crystallizes the raging conflict between the establishment
point of view that HIV is deadly and drugs save lives and the "denialist"
or dissident point of view that HIV is not deadly at all by itself, but
AIDS drugs are. Hafford had no so-called AIDS symptoms; she was simply HIV
positive. She also had an older healthy child, which suggests that HIV may
not be as lethal as advertised. By refusing to lament her death, or even
the scores of Ugandan deaths, and instead attacking the messenger, the
AIDS establishment has shown itself to be lost, with a broken compass, on
the map of medicinal ethics.
Once it becomes acceptable to kill patients in experimental clinical
trials and cover it up, without
